iClean

ValGenesis iClean™ is a digital cleaning validation platform designed for life sciences and pharmaceutical manufacturers seeking to modernize and standardize their cleaning validation programmes. It digitalizes the entire cleaning validation lifecycle—from risk-based planning and MACO determination through execution and ongoing requalification—enabling teams to achieve audit readiness across all global sites while significantly reducing cycle times and manual effort.

iClean is purpose-built for organizations managing complex, multi-site cleaning validation requirements. By automating calculations, integrating ADE/NOAEL-based scientific data, and applying business-rule-driven decision trees, the platform helps validation teams eliminate errors, enforce residual limits consistently, and maintain global compliance even as processes evolve.

Core Capabilities

• Automated MACO (Maximum Allowable Carryover) calculations based on HBELs such as ADE/PDE or user-defined criteria, accounting for shared surface areas, batch sizes, and additional attributes down to the material level
• Worst-case product evaluation based on ADE/PDE potency, solubility, toxicity, and difficulty to clean, ensuring a conservative, risk-based approach
• 2D and 3D digital equipment mapping that applies risk-based logic to each equipment part, enabling users to identify and insert appropriate sampling locations directly on the models
• Automatic embedding of sampling plans into validation and verification protocols, streamlining compliance and traceability
• Centralized method and cleaning agent repository for consistent management of cleaning procedures and critical process parameters
• Version-controlled storage of all cleaning procedures, equipment-specific parameters (e.g., temperature, time, flow), and validation data with full audit trail visibility
• Built-in residual limit enforcement and business-rule-driven decision trees to reduce manual work and eliminate calculation errors

Global Standardization and Local Flexibility

• Centralized cleaning strategies that can be adapted to site-specific and equipment-specific validation protocol requirements
• Global standardization of cleaning validation programmes while maintaining the flexibility to accommodate local regulatory and operational needs
• Change control and requalification workflows that ensure sustained compliance as manufacturing processes evolve

Oversight, Analytics, and Compliance

• Real-time visibility into validation status, risks, and readiness across all sites through built-in analytics and intelligent dashboards
• 100% digital documentation and traceability supported by automated audit trails
• Inspection-ready documentation delivered faster through automation of validation cycles and reporting
• Compliance status visibility and change management capabilities maintained within the platform

Workflow Integration

• End-to-end digitalization of the cleaning validation lifecycle, from initial risk-based planning through requalification
• Automated protocol generation with sampling plans embedded directly from digitized equipment models
• Integration of ADE/NOAEL-based scientific data to support scientifically justified residue limits
• Designed to operate as part of the ValGenesis Validation Lifecycle Suite alongside other ValGenesis products

ValGenesis iClean™ is positioned to help pharmaceutical and life sciences organizations cut cleaning validation cycle times by up to 50%, reduce audit risk, and eliminate the bottlenecks associated with manual, paper-based, or spreadsheet-driven cleaning validation programmes. The platform supports compliance with FDA and global regulatory expectations, including addressing common FDA 483 cleaning validation observations.